US4810241A - Ambulatory dialysis system and connector - Google Patents

Abstract

An ambulatory dialysis system and connector which effectively prevents peritoneal infections such as peritonitis. The connector is comprised of a cylinder containing a disinfecting solution which continuously bathes the male and female connectors of a tube during use. A highly absorbent material is packed in the cylinder and saturated with a disinfectant and bathes the male and female connectors when connection is made and continually bathes them during use. A connection is provided by a male fitting on the end of a tube connected to a container of dialysate fluid or an abdominal opposing tube. A male connector is inserted into the female connector through the cylinder containing the absorbent material saturated with the disinfectant. The absorbent material is packed such that the male connector contacts the absorbent material during insertion to disinfect the opposing ends simultaneously while connection is being made. Once the dialysate fluid is delivered to the patient through the connector, the tube may be pulled off the outer end of the male connector to remove the empty containers. The male connector is then sealed and capped.

Description

This application is a continuation of application Ser. No. 490,978, filed May 2, 1983, now U.S. Pat. No. 4,655,762, which is in turn a continuation-in-part of application Ser. No. 431,333, filed Sep. 30, 1982, now U.S. Pat. No. 4,551,146, which in turn is a continuation-in-part of application Ser. No. 157,268, filed June 10, 1980, now U.S. Pat. No. 4,354,490.

BACKGROUND OF THE INVENTION

This invention relates to connectors for use with ambulatory dialysis devices and more particularly relates to an apparatus which disinfects the connection during connection and use.

There is a new system available for treating patients with loss of kidney function in which a container or bag of dialysate fluid is connected to the abdominal cavity for the purpose of peritoneal dialysis. In this system, the container with the dialysate fluid is connected to a permanent abdominal tube and the dialysate fluid is allowed to flow into the peritoneal cavity. The container and the tubing are then wound around the waist and tied. The dialysate fluid is allowed to remain in the peritoneal cavity for a period of time, allowing toxic waste and water to pass into the fluid. At the end of a predetermined period of time, the container is lowered and the fluid is allowed to flow out and back into the original container. The container is then disconnected and discarded and a new container of dialysate fluid attached to the permanent abdominal tube and the process is repeated.

A frequent problem which occurs from this method of peritoneal dialysis is the danger of peritoneal infection or peritonitis which is extremely high, due to the disconnecting and reattaching of containers with the dialysate fluid. These infections have been occurring even when extreme caution has been taken in making these connections and disconnections. The present method of making the interchange is to thoroughly cleanse the ends of the tubes connected respectively to the container of dialysate fluid and the abdominal connector before the connection is made. Further, as another precaution, the connection is made with surgically sterile rubber gloves to prevent or guard against any possible peritoneal invasion of bacteria.

Even with these precautions, incidents of peritoneal infection or peritonitis are still high. It would be advantageous if the disconnection and reconnection could be made without going through the time-consuming and very great inconveniencing process of putting on surgically sterile gloves, cleaning both tubes, and then connecting a new container of dialysate fluid. It would also be advantageous if the necessity for carrying around the empty container could be eliminated.

SUMMARY OF THE INVENTION

The purpose of the present invention is to permit patients who are on ambulatory peritoneal dialysis systems to make connections and disconnections with a minimum of danger of peritoneal infection.

The present invention was conceived to allow disconnecting and reconnecting a new container of peritoneal dialysis fluid which minimizes the possibility of any invasion of bacteria into the peritoneal cavity. In the present invention, the male and female connections to the tubes connected to the container of dialysate fluid and the abdominal connector respectively are surrounded with a disinfectant during the connection and while the dialysate fluid is in use. To accomplish this a cylinder is packed with an absorbent material which is saturated with a disinfectant fluid. As the male and female ends of the respective tubes are brought into engagement they pass through the saturated absorbent material and are connected. The absorbent material contained in the cylinder remains around the connection during the entire use of the dialysate fluid. When a new container of dialysate fluid is to be attached, the same procedure is repeated, in that the respective ends of the tube are again bathed in disinfectant during and after connection and continuously while in use.

One embodiment further minimizes the danger of contamination of the ends of the tubes being connected. In this embodiment the cylinder is formed as two open-ended, telescoping cylinders which close around the connection of the male and female ends of the tubes and lock them together. An additional advantage of this device is that the open-ended cylinders are attached to and surround the respective male and female end connections of the tubes, acting as shields to minimize any danger of contaminating contact with the ends before, during or after a connection.

A further optional but desirable improvement permits the removal of the empty container leaving the connectors joined. The male connector is provided with a valve having a stem which seals the outer end of the male connector after the delivery of the dialysate fluid to the patient. The tube connected to the empty container may then be pulled out of the connector, disconnecting the container from the patient. A cap is then inserted in the hole at the outer end of the male connector to protect against the invasion of any bacteria. If desired, tape can be wound around the end of the connector to prevent the cap or valve stem from being dislodged. In this manner the patient is relieved from the necessity of carrying around the empty container. The patient now only carries around a short length of tube and the sealed connector.

In conjunction with the improvement described above, the Continuous Ambulatory Peritoneal Dialysis (CAPD) connector includes a system for the transfer (i.e. removal and replacement) of the dialysate fluid. Two containers are provided, connected to the male connector through a two-way valve and split tubing. One container is empty to receive used, discharged dialysate fluid, while the other container contains fresh dialysate fluid. The used dialysate fluid is discharged into the empty container, the valve is switched and the fresh dialysate fluid is transferred to the patient. Both containers are simultaneously disconnected and the connector sealed as described above.

It is one object of the present invention to provide a connector for patients using continuous ambulatory peritoneal dialysis.

Another object of the present invention is to provide a method and apparatus for continuously bathing a connector between a bag of dialysate fluid and a tube to an abdominal cavity with a disinfecting solution.

Still another object of the present invention is to provide a method and apparatus for making a connection for continuous ambulatory peritoneal dialysis which is simple and easy to use.

Yet another object of the present invention is to provide a method of connecting a bag of dialysate fluid for continuous ambulatory peritoneal dialysis which provides shields for the end of the tubes being connected to prevent contamination.

Still another object of the present invention is to provide means for sealing the connector and removing the dialysate container after delivery of dialysate fluid to the patient.

A further object of the present invention is to provide a CAPD system which permits the removal of the dialysate containers.

These and other objects of the invention will become apparent from the following detailed description when considered in conjunction with the drawings, wherein like reference numbers identify like parts throughout.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded view of the first embodiment of the peritoneal dialysis connector of the present invention.

FIG. 2 is a sectional view of one end of the peritoneal dialysis connector.

FIG. 3 is a partial sectional view of the end of the peritoneal dialysis connector prior to connection.

FIG. 4 is a sectional view illustrating the connection of the peritoneal dialysis connector of the present invention.

FIG. 5 is an alternate embodiment of the peritoneal dialysis connector.

FIG. 6 is a sectional view illustrating the peritoneal dialysis connector of FIG. 5.

FIG. 7 is a sectional view of the peritoneal dialysis connector of FIG. 5 illustrating the device being connected.

FIG. 8 is a sectional view showing an alternate embodiment of the peritoneal dialysis connector illustrated in FIG. 2.

FIG. 9 illustrates a connector which permits removal of dialysate container.

FIG. 10 is a sectional view taken at 10--10 of FIG. 9.

FIG. 11 is a sectional view similar to FIG. 10 illustrating the removal of dialysate container and sealing of the connector.

FIG. 12 is a sectional view similar to FIG. 10 showing the dialysate container tube removed and the connector sealed.

FIG. 13 illustrates the storage of a sealing end cap before use.

FIG. 14 illustrates a Continuous Ambulatory Peritoneal Dialysis system for use with the connector of FIGS. 9 through 12.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring to FIG. 1, the peritoneal dialysis connector is comprised ofcylinder 10 which attaches tocollar 17 onfirst tube 16. A second open-ended cylinder 11 is attached to the end of aseparate tube 18 for telescopic engagement with thefirst cylinder 10 which will be described in greater detail hereinafter. Also provided with the device is plug 15 for sealing the end ofcylinder 10, as will be described hereinafter.

Cylinder 10 on the end oftube 16 is illustrated in greater detail in FIG. 2. Inside cylinder 10 a packing ofabsorbent material 12, such as a sponge, is provided. This sponge is saturated with a disinfectant solution, such as Betadine.Cylinder 10 is attached tocollar 17 by a suitable adhesive. Withcylinder 10 connected tocollar 17, the disinfectant solution inabsorbent material 12 cleanses the end oftube 16.Cap ring 19 closes the opposite end ofcylinder 10.Cap ring 19 is provided with groove 1 for engagement byridge 23 onplug 15. The end ofcylinder 10 is sealed byplug 15 by inserting the plug untilshank 40 engages the end oftube 16 andridge 23 locks into place ingroove 21 withcover 38 closing and sealing the opening incap ring 19. This seals the cylinder until it is ready to use, preventing bacterial contamination and evaporation of the disinfectant solution.

Theother tube 18 has a cylinder orsleeve 30 attached to it as shown in FIG. 3.Cylinder 30 extends beyond the end oftube 18, preventing contact with fingers or any potential contaminating means. The end oftube 18 is provided withridge 20 similar toridge 23 onplug 15.Open end 31 ofcylinder 30 may be closed in some fashion by a wrapping or some other suitable means prior to use to minimize the possibility of contamination during shipment.

To use the device, plug 15 is removed fromcap ring 19 by pulling onring 13. This openscylinder 10 for insertion of the end oftube 18.Tube 18 passes through opening 11 incylinder 10 and engagesend tube 16. Simultaneouslycylinder 30 telescopically engagescylinder 10.Passageway 22 inabsorbent material 12 is intentionally slightly smaller than the outside diameter oftube 18, causing the tube to engage the absorbent material and be bathed in disinfectant solution as the connection is being made. Whentube 18 is fully inserted incylinder 10,rib 20 will engage groove 21 as illustrated in FIG. 4.

To lock the connection, a pair of L-shapedslots 34 are provided incylinder 30 which engage lugs 32 oncylinder 10.Lugs 32 slide intoslots 34 and by a slight twisting motion are locked in the leg of L-shapedslot 34. Thustube 18 is connected totube 16 and is completely sealed and surrounded by the connection oftelescoping cylinders 10 and 30. Also, disinfectingsolution 12 has bathed the ends oftubes 16 and 18 during connection and continues to bathe the ends during use.

As can be seen, the connection can be made by graspingtubes 16 and 18 behind the ends oftelescoping cylinders 10 and 30 and no contact with the ends of the tubes need be made. Further, the connection is cleansed, disinfected and simultaneously connected in the minimum amount of time substantially eliminating the possibility of contamination.

An alternate construction is illustrated in FIGS. 5 through 7. In this embodiment,cylinder 40 is separate from the connectors and hasend connectors 42 and 44 sealed tocylinder 40 by suitable adhesive. The interior ofcylinder 40 hasabsorbent material 46 suitably saturated with a disinfecting solution as before. In this embodiment, however,passageway 48 between the open ends and end 52 is tapered toward the center and is generally smaller in diameter thantubes 56 and 58.Grooves 60 and 62 are provided which mate withribs 64 and 66 on the respective tubes; to sealopenings 50 and 52 when the tubes are in engagement.Tubes 56 and 58 are also provided withgrooves 68 and 70 for locking the connection by means of pivotinghooks 72 and 74, as will be described hereinafter.

To make this connection,male tube 56 would be inserted through opening 50 incylinder 40 untilridge 64 locks ingroove 60 and the tube is secured byhook 72. Theother tube 58 would then be inserted throughhole 52 incylinder 40 until it engages the end oftube 56, as shown in FIG. 7. Preferably, the tube having the male connector is inserted first. The outside of the tube will be completely bathed in disinfecting solution, thus carrying some disinfecting solution into the interior of the female connector, in thiscase tube 58.Tube 58 is inserted untilridge 66 locks intogroove 62 andhook 74 is then fitted into engagement withslot 70 locking the device together. Thus, the connection oftubes 56 and 58 is made through a disinfecting solution which continues to bathe the connection during the use of the dialysate fluid.

A disadvantage of the second embodiment is that the ends oftubes 56 and 58 may be exposed for a brief period. Since the danger of bacterial infection is great, it is preferable to shield the ends of the tubes, as shown in the embodiment of FIG. 1 or minimize their exposure to as brief a period as possible. In the latter embodiment, however,cylinder 40 is not fixed totube 56 and can be replaced as desired. Alternately,cylinder 10 on the embodiment of FIGS. 1 through 4 could be made removable in the manner illustrated with the embodiments of FIGS. 5 through 7. Also preferablycylinder 10 with the absorbent packing would be provided on the tube connected to the container of dialysate fluid for repacement each time a connection is made. Thus, a fresh supply of disinfecting solution inabsorbent material 12 will be provided with each connection.

An alternate method of sealingcylinder 10 on the end oftube 16 is shown in FIG. 8. This method combines a second cylinder with a plug similar to plug 15 of FIG. 2.Plug 75 is provided withshank 76,shoulder 78 andcylinder 80 attached to coverplate 82.Cap ring 84 is formed integrally withcylinder 86 and has a groove orrecess 88.Shoulder 78 on the plug hasridge 92 engaginggroove 88 to retain the plug on the connector.

In addition to the retention ofridge 92 in recess 88 a positive locking mechanism may be provided in the form ofposts 94 and 96 engaging and locking intoslots 98 and 100 ofcylinder 80. This would be a twist locking action applied to ring 102 similar to that illustrated in FIG. 4. Whenplug 75 is fully pushed in and locked,ridge 92 will seat in recess 8 andshank 76 will engage the inner end oftube 104.

An optional but preferred embodiment which permits the removal of the dialysis container or container after transfer of the dialysate fluid to the patient, is illustrated in FIGS. 9 through 14. In FIG. 9, the connector is shown joined withfemale connector 30 being locked onto a modifiedmale connector 110. This will be the connector arrangement immediately after connection and transfer of dialysate fluid to the patient. The patient may close and seal the connector and remove the empty container, as illustrated in FIGS. 10 through 12.

Retainer 112 is provided to keepvalve 114 open while dialysate fluid is being transferred throughtube 116 to the patient throughtube 18.Retainer 12 is a "wishbone" shaped yoke placed around the cylindrical body ofmale connector 110 havingslot 118 engagingvalve 114.Retainer 112 snugly fits the outside circumference ofmale connector 110, keepingvalve 114 from being prematurely closed.

Valve 114 hasstem 120 constructed to fit countersunkbore 122 inclosure 117 on the outer end ofmale connector 110.Valve stem 120 has a close tolerance fit inbore 122 to prevent it from being dislodged after it is closed. When closed the head onvalve 114 seats in thecountersunk bore 122 flush with the outside surface.Closure 117 on the end of themale connector 110 also hassocket 124 for receivingconnector 126 attached to the end oftubing 116.Connector 126 hasridge 128 for snap-lockingtubing 116 toclosure 117. Themale connector 110 is provided withabsorbent material 130 as in the previous embodiments, surroundinginner extension 132 oftubing 116.

The closing and sealing of the connector is illustrated in FIGS. 11 and 12. After dialysate fluid has been completely transferred to the patient,retainer 112 is pulled off the connector, releasingvalve 114. Pressure applied to the head of the valve, as illustrated byarrow 134, forces valve stem 120 downward into the connector until it is fully seated with the head flush with the surface, closing off the pathway fromtubing 116 through the connector.Connector 126 andtubing 116 may now be pulled out ofsocket 128 removing the empty dialysate container fromconnector 110. The patient is now effectively disconnected from any containers and has only a small length oftube 18 and the joined connector to contend with.

As a further safety feature,end cap 136 provided in a connector kit in a small sealed container 138 (FIG. 13) is then inserted intosocket 128.End cap 136 has apost 140 and a small pad ofabsorbent material 142 saturated with a disinfectant, such as betadine. When installed, thepost 140 fits tightly insocket 128 with disinfectant saturatedabsorbent pad 142 abutting valve stem 120 as illustrated in FIG. 12. This feature provides positive assurance that no bacteria could get into the interior of the connector through the open end ofmale connector 110. The connector disclosed and described provides a relatively simple solution to connecting and disconnecting during a CAPD procedure. Whilestem 120 and post 140 onend cap 136 tightly fit their respective sockets and are unlikely to come out, it is preferable that the extra precaution ofadhesive tape 144 wrapped around the outer end ofmale connector 110 be taken to further assure a safe, positive seal. The patient now has only the short length oftube 18 and the joined connectors to lug around.

To use the connecting device illustrated in FIGS. 9 through 12 a CAPD system, shown schematically in FIG. 14, has been designed. A joined connector is illustrated at 146 connected bytubing 18 andvalve 148 to the peritoneum of the patient.Tubing 116 is connected through two-way valve 150 toempty dialysate container 152 andfull dialysate container 154 bytubing 156 and 158 respectively. To use the system illustrated, the capped and sealed male connector illustrated in FIGS. 9 through 12 is separated from thefemale connector 30 and discarded. A new male connector, havingretainer 112 in place, is then mated and secured to the female connector. (Of course, the male connector will come with aprotective plug 102 in place, as shown in FIG. 8, which must first be removed.) This connectsempty dialysate container 152 to the patient through the connector andvalve 148.Valve 148 may now be opened, draining used dialysate fluid through two-way valve 150 into the empty dialysate container. Once all the used dialysate fluid has been drained, two-way valve 150 is switched fromtube 156 totube 158 connected to the full container ofdialysate fluid 154. The fresh dialysate fluid may now be transferred to the patient. After completion of delivery of the fresh dialysate fluid,valve 148 is closed.

At thispoint valve 114 is closed andtubing 116 andconnector 126 may be disconnected from the male connector.End cap 136 is then inserted in the end of the connector to seal it andtape 144 wrapped around the end, as illustrated in FIG. 12.

Thus there has been disclosed a CAPD system and connector for transferring dialysate fluid to and from a patient which is both safe, simple and easy to use. The system permits the patient to remove the empty dialysate container so that he does not have to carry it around unnecessarily. The connector effectively prevents infection of the peritoneal cavity while CAPD is in use.

Obviously, many modifications and variations of the present invention are possible in light of the above teachings. It is to be understood that the scope of the invention is to be limited only by interpretation of the appended claims.

Claims (3)

What is claimed is:

1. A method of protecting a tube connection from contamination during peritoneal dialysis comprising;

forming cylindrical means;

packing said cylindrical means with an absorbent material substantially filling said cylindrical means;

saturating said absorbent packing material with a disinfectant;

surrounding a connection site of first and second telescopically mating tube ends with said cylindrical means packed with said saturated absorbent material;

said saturated absorbent material being kept in continuous intimate contact with said connection of said first and second telescopically mating tube ends throughout use;

whereby said connection of said telescopically mating tube ends is continuously protected from contamination throughout use.

2. The method according to claim 1 in which said cylindrical means is formed as a pair of telescopically mating cylinders on each end of said first and second telescopically mating tube ends whereby one of said telescopically mating tube ends is pushed through said saturated absorbent packing material to mate with the other of said mating tube ends.

3. The method according to claim 2 including forming locking means on said telescopically mating cylindrical means; whereby said telescopically mating cylindrical means are locked together around said telescopically mating tube ends after the connection is made.

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